Buscopresc 20 mg solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Buscopresc 20 mg injectable solution

Butylscopolamine bromide

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, since it could harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Buscopresc is and what it is used for
2. What you need to know before using Buscopresc
3. How to use Buscopresc
4. Possible adverse effects
5. Storage of Buscopresc
6. Contents of the pack and other information

1. What Buscopresc is and what it is used for

The active ingredient in Buscopresc belongs to a group of medicines known as semisynthetic Belladonna alkaloids, quaternary ammonium compounds. It exerts an antispasmodic effect on the smooth muscle of the gastrointestinal, biliary, and genitourinary tracts.

Buscopresc is used in adults and adolescents over 12 years of age, as well as in children and infants, for the treatment of acute spasms of the gastrointestinal, biliary, and genitourinary tracts, including biliary and renal colic. It is also used as an adjunct in diagnostic and therapeutic procedures where spasm may pose a problem, such as gastro-duodenal endoscopy and radiology.

2. What you need to know before using Buscopresc

Do not use Buscopresc

• If you are allergic to butylscopolamine bromide or to any of the other components of this medicine (listed in section 6).
• If you have increased eye pressure (narrow-angle glaucoma) and are not being treated for it.
• If you have prostate enlargement (benign prostatic hyperplasia).
• If you have urinary retention due to any urethro-prostatic pathology.
• If you have mechanical gastrointestinal obstruction (narrowing of the gastrointestinal tract) or pyloric stenosis (narrowing of the pylorus).
• If you have paralytic ileus (intestinal paralysis) or obstructive ileus (intestinal obstruction).
• If you have megacolon (abnormally enlarged colon).
• If you have tachycardia.
• If you have myasthenia gravis (a chronic disease characterized by varying degrees of muscle weakness).
• In patients being treated with anticoagulant medications, as intramuscular hematomas may occur. In these patients, Buscopresc should be administered subcutaneously or intravenously.

Inform your ophthalmologist if, after receiving Buscopresc, you experience eye pain and redness accompanied by vision loss, as this may indicate undiagnosed narrow-angle glaucoma (an eye condition involving increased pressure).

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Buscopresc.

Take special care with Buscopresc if you are predisposed to intestinal or urinary obstructions.

Cases of anaphylaxis, including episodes of shock, have been observed after parenteral administration of Buscopresc. As with all medicines that can cause such reactions, you will be monitored if Buscopresc is administered to you.

If severe abdominal pain of unknown origin persists or worsens, or occurs with symptoms such as fever, nausea, vomiting, changes in bowel movements, abdominal tenderness, low blood pressure, fainting, or presence of blood in stools, consult your doctor immediately.

Caution is required in patients with cardiac conditions receiving parenteral treatment with Buscopresc. Monitoring of these patients is recommended.

Other medicines and Buscopresc

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

You must inform your doctor if you are taking any of the following medicines concurrently:

• Medicines for the treatment of depression (tricyclic and tetracyclic antidepressants).

• Medicines for the treatment of allergies (antihistamines).

• Medicines for the treatment of certain mental disorders (antipsychotics).

• Medicines for the treatment of cardiac arrhythmias (quinidine, disopyramide).

• Medicines for the treatment of heart failure and/or asthma (digoxin, beta-adrenergics).

• Medicines for the treatment of viral infections and/or Parkinson’s disease (amantadine).

• Medicines for the treatment of nausea/vomiting and/or gastric motility paralysis (dopamine antagonists, e.g., metoclopramide).

• Other anticholinergic drugs (e.g., tiotropium, ipratropium, and atropine-like compounds).

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

The use of Buscopresc is not recommended during pregnancy and breastfeeding.

Driving and using machines

During treatment with Buscopresc 20 mg injectable solution, you may experience undesirable effects such as visual accommodation disturbances and dizziness. Do not drive or operate machinery after parenteral administration of Buscopresc 20 mg injectable solution if you experience these side effects, until your vision returns to normal.

Buscopresc contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per ampoule; hence, it is essentially “sodium-free”.

3. How to use Buscopresc

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose for adults and adolescents over 12 years of age is 1–2 ampoules (20–40 mg), several times daily.

The maximum daily dose must not exceed 100 mg of butylscopolamine bromide (5 ampoules of Buscopresc).

Dose adjustment is not required in patients with renal and/or hepatic impairment.

It must be administered by slow intravenous, intramuscular, or subcutaneous injection.

The optimal duration of symptomatic treatment depends on the indication, and short-term treatment is recommended.

Buscopresc must not be administered continuously or for long periods of time without identifying the cause of abdominal pain.

Use in children and infants

In severe cases, a dosage of 0.3–0.6 mg per kg of body weight is recommended, given several times daily.

The maximum daily dose must not exceed 1.5 mg of butylscopolamine bromide per kg of body weight.

If you use more Buscopresc than you should

Anticholinergic symptoms may occur (such as urinary retention, dry mouth, skin flushing, tachycardia, inhibition of gastrointestinal motility, and transient visual disturbances).

If you have used more Buscopresc than you should, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20.

Information for the physician:

If necessary, parasympathomimetics may be administered. Patients should urgently consult an ophthalmologist in case of glaucoma. Cardiovascular complications should be managed according to standard therapeutic measures. In case of respiratory paralysis, intubation and artificial respiration should be performed. Catheterize in case of urinary retention.

In addition, appropriate supportive measures should be applied as needed.

If you forget to use Buscopresc

Do not administer a double dose to make up for missed doses.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The adverse effects described are:

• Common (may affect more than 1 in 10 people): visual accommodation disorders, tachycardia, dizziness, dry mouth.
• Frequency not known (cannot be estimated from available data): shock due to a severe allergic reaction, which may lead to death (anaphylactic shock with possible fatal outcome), reaction caused by an allergy (anaphylactic reaction), difficulty breathing (dyspnea), skin reactions, urticaria, skin rash (exanthema), redness of the skin (erythema), itching, hypersensitivity, pupil dilation, increased pressure inside the eye, decreased blood pressure, flushing, abnormal sweating, difficulty urinating (urinary retention).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Buscopresc

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Buscopresc

The active substance is butylscopolamine bromide. Each 1 ml injectable solution contains 20 mg of butylscopolamine bromide.

The other components are sodium chloride and water for injectable preparations.

Appearance of the product and contents of the pack

Clear, colourless to almost colourless solution.

It is supplied in colourless glass ampoules containing 1 ml of injectable solution, in packs of 6 ampoules and in a clinical pack of 50 ampoules.

Marketing Authorisation Holder

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 – Barcelona

Spain

Sanofi Group

Manufacturer

Boehringer Ingelheim España, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallès (Barcelona)

Spain

or

Sanofi S.r.l.

Via Valcanello 4,

03012 Anagni (Frosinone)

Italy

Date of the most recent review of this leaflet:

Detailed information on this medicinal product is available by scanning with your mobile phone (smartphone) the QR code included in the packaging and leaflet. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/18220/P_18220.html

Up-to-date and detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.